| CTRI Number |
CTRI/2025/12/099394 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of prescribing patterns of proton pump inhibitors in patients with acid reflux disorder |
|
Scientific Title of Study
|
Drug utilization study of proton pump inhibitors in patients with acid reflux disorder in tertiary care hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devika Nechikat |
| Designation |
Pharm D Intern |
| Affiliation |
Indus International Hospital |
| Address |
Department of clinical trial Indus International hospital Chandigarh Ambala Highway Derabassi
SAS Nagar
Rupnagar
PUNJAB
140507
India |
| Phone |
7337492020 |
| Fax |
|
| Email |
devika26042002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parminder Kaur |
| Designation |
Medical Superintendent |
| Affiliation |
Indus International Hospital |
| Address |
Admin block, ground floor, Indus International hospital Chandigarh Ambala Highway Derabassi
SAS Nagar
Rupnagar
PUNJAB
140507
India |
| Phone |
8872735888 |
| Fax |
|
| Email |
msiih@indushospitals.com |
|
Details of Contact Person
Public Query
|
| Name |
Avantika Chandra |
| Designation |
Manager Clinical Research Department |
| Affiliation |
Indus International Hospital |
| Address |
Department of clinical trial Indus International hospital Chandigarh Ambala Highway Derabassi
SAS Nagar
Rupnagar
PUNJAB
140507
India |
| Phone |
7991451277 |
| Fax |
|
| Email |
avantikabiotech2017@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indus International Hospital |
| Address |
Chandigarh Ambala road Derabassi Mohali Punjab 140507 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Avantika Chandra |
Indus International Hospital |
Department of clinical trial. Indus International hospital Chandigarh Ambala Highway Derabassi
SAS Nagar
Rupnagar
PUNJAB
140507
India
Department of clinical trial. Indus International hospital Chandigarh Ambala Highway Derabassi
SAS Nagar
Rupnagar
PUNJAB
140507
India
Rupnagar
PUNJAB |
7991451277
avantikabiotech2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indus International Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of all age groups and both sexes
Patients with a primary or secondary diagnosis of acid reflux disorders
Patients receiving at least one PPI during their hospital stay |
|
| ExclusionCriteria |
| Details |
Patients not diagnosed with acid reflux disorders
Patients not receiving PPIs
Patients with incomplete medical records |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Identifying the PPI that is most commonly prescribed in hospital settings
A qualitative and quantitative examination of PPI prescription trends.
Calculation of the proportion of irrational versus sensible PPI prescriptions according
to indication, dosage, and length of time |
baseline, day 7, and 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The rate of prolonged therapy or improper prophylactic usage is estimated.
The creation of evidence-based guidelines for the sensible prescription of PPIs, which
can be shared with physicians to enhance practice habits. |
baseline, day 7, & 6 month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Proton pump inhibitors (PPIs) are very effective drugs that drastically lower gastric acid output by permanently blocking the gastric H+/K+ ATPase enzyme, which is found in the stomach’s parietal cells. They stand in for the key component of treatment for acidpeptic conditions such as GERD, peptic ulcer disease, Zollinger- Ellison syndrome, and for preventing stress-induced mucosal bleeding in patients in critical condition? Due to their abilit y to suppress acid quickly and effectively compared to H2-receptor antagonists, PPIs are now one of the most often prescribed medication classes globally Despite the widespread use of PPIs, there remains a knowledge gap regarding the appropriateness of their prescription in hospital settings, particularly in relation to GERD management. Comprehensive evaluation of prescribing practices in such a context is crucial for ensuring that patients receive therapy in alignment with evidence-based recommendatio ns. Furthermore, understanding the trends in PPI utilization can provide useful information for physicians, pharmacists, and policymakers to design interventions aimed at improving rational prescribing. |